Adrenalin Chloride Solution — Class I drug recall D-0223-2025
Ongoing recall by ENDO USA, Inc., reported 2025-02-12, distributed nationwide. Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Ad
| Recall number | D-0223-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ENDO USA, Inc., Rochester, MI, United States |
| Recall initiated | 2024-12-20 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 44,397 amber |
| Reason classes | labeling |
| NDC | 42023-0103-01 |
Product
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Reason for recall
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0223-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.